Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients (TRASCO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00902109
First received: May 12, 2009
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.


Condition Intervention
Primary Open Angle Glaucoma (POAG)
Device: Perimetry
Device: Confocal Scanning Laser Tomography
Device: Optical Coherence Tomography (OCT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Compare the Humphrey Field Analyzer (HFA) 30-2 Swedish Interactive Threshold Algorithm (SITA) Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE), Using a New Fast GATE (German Adaptive Threshold Estimation) in Glaucoma Patients Under Topic Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Comparison of rate of progression [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    Perimetric measures every 3 month over 3 years


Estimated Enrollment: 12
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
perimetry, HRT, OCT
perimetry, HRT, OCT
Device: Perimetry
different perimetric devices, different perimetric grids: Octopus: New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) HFA: 30-2, Sita (Swedish Interactive Thresholding Algorithm) full threshold
Other Name: Humphrey Field Analyzer 745i (HFA), Interzeag Octopus 101
Device: Confocal Scanning Laser Tomography
HRT examinations for the clinical evaluation of the optic disc.
Other Name: Heidelberg Retina Tomograph (HRT)
Device: Optical Coherence Tomography (OCT)
imaging of the retinal nerve fiber layer
Other Name: Spectralis-OCT (Heidelberg Engineering, Heidelberg, Germany)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University Eye Hospital

Criteria

Inclusion Criteria:

  • primary open angle glaucoma (POAG)
  • spherical ametropia max. ± 8 dpt
  • cylindrical ametropia max. ± 3 dpt
  • distant visual acuity > 10/20
  • pupil diameter > 3 mm

Exclusion Criteria:

  • diabetic retinopathy
  • asthma
  • history of epilepsy or significant psychiatric disease
  • medications known to effect visual field sensitivity
  • infections (e.g., keratitis, conjunctivitis, uveitis)
  • severe dry eyes
  • miotic drug
  • squint
  • nystagmus
  • albinism
  • any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields
  • keratoconus
  • intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
  • history or signs of any visual pathway affection other than glaucoma
  • history or presence of macular disease and/or macular edema, ocular trauma, medications known to affect visual field sensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902109

Locations
Germany
Institute for Ophthalmic Research
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Alcon Research
Investigators
Principal Investigator: Ulrich Schiefer, Prof. Dr. med. University Hospital Tuebingen
  More Information

Publications:
Responsible Party: Ulrich Schiefer, Prof. Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00902109     History of Changes
Other Study ID Numbers: SCOPE-G-BETA
Study First Received: May 12, 2009
Last Updated: May 22, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
visual field
perimetry
progression
POAG
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014